There is a strong, inverse association between midlife cardiorespiratory fitness and stroke risk in later life, independent of the baseline and antecedent burden of risk factors, according to a study published online ahead of print June 9 in Stroke. Researchers studied 19,815 individuals who received Medicare coverage from 1999 to 2009. Cardiorespiratory fitness estimated at baseline was analyzed as a continuous variable and according to age- and sex-specific quintiles. Associations between midlife cardiorespiratory fitness and stroke hospitalization after age 65 were assessed by applying a proportional hazards recurrent events model to failure time data with hypertension, diabetes mellitus, and atrial fibrillation as time-dependent covariates. The investigators observed 808 stroke hospitalizations. After adjustment for baseline risk factors, higher midlife cardiorespiratory fitness was associated with a lower risk of stroke hospitalization.

Incident dementia early after intracerebral hemorrhage is strongly associated with hematoma size and location, according to a study published online ahead of print June 13 in JAMA Neurology. A longitudinal study enrolled patients with intracerebral hemorrhage from January 1, 2006, to December 31, 2013. In all, 738 participants ages 18 or older, without pre-intracerebral hemorrhage dementia, who presented to a tertiary care academic institution with primary intracerebral hemorrhage were included in the study. A total of 140 patients developed dementia within six months. Larger hematoma size and lobar location of intracerebral hemorrhage were associated with early post-intracerebral hemorrhage dementia, but not with delayed post-intracerebral hemorrhage dementia. Educational level, incident mood symptoms, and white matter disease were associated with delayed, but not early, post-intracerebral hemorrhage dementia.

The FDA is investigating the risk of serious burns and potential permanent scarring from the use of the Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine. The patch delivers a dose of medicine in a single-use, battery-powered patch that is wrapped around the upper arm or thigh. Since the introduction of the patch, many patients have reported injury to the skin where the patch was worn. The reports include descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. Patients who experience moderate to severe pain at the patch site should immediately remove the patch to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact a health care professional. Teva Pharmaceuticals has suspended the sale, marketing, and distribution of the patch.

More than 90% of the global stroke burden is attributable to modifiable risk factors, including air pollution, and controlling behavioral and metabolic risk factors could avert more than 75% of the global stroke burden, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers used data on stroke-related disability-adjusted life-years, risk factors, and population-attributable fraction from the Global Burden of Disease Study 2013 to estimate the burden of stroke by age and sex in 188 countries. Approximately 74% of the global stroke burden was attributable to behavioral factors. Clusters of metabolic factors (72%) and environmental factors (33%) were the second and third largest contributors to disability-adjusted life-years, respectively. About 29% of the burden of stroke was attributed to air pollution.

Abnormally high fractional anisotropy (FA) on diffusion tensor imaging (DTI) is associated with better outcomes after mild traumatic brain injury (mTBI), according to a study published online ahead of print June 9 in the American Journal of Neuroradiology. DTI was performed on 39 subjects with mTBI within 16 days of injury and on 40 controls. In all, 26 subjects with mTBI returned for follow-up at one year. Among these subjects, high FA in the left frontal lobe and left temporal lobe was associated with better attention. High FA in the left and right cerebelli was associated with improved somatic postconcussion symptoms. High FA in the right thalamus was associated with improved emotional postconcussion symptoms. Abnormally high FA may be an imaging correlate of postinjury compensatory processes, said the investigators.

Among patients with multiple sclerosis (MS), obstructive sleep apnea and sleep disturbance are significantly associated with diminished visual memory, verbal memory, executive function, attention, processing speed, and working memory, according to a study published online ahead of print May 3 in Sleep. Thirty-eight participants underwent MS-specific cognitive testing and in-laboratory overnight polysomnography. In adjusted linear regression models, the oxygen desaturation index and minimum oxygen saturation were significantly associated with performance on multiple Minimal Assessment of Cognitive Function in MS measures. Apnea severity measures accounted for between 11% and 23% of the variance in cognitive test performance. Polysomnographic measures of sleep fragmentation and total sleep time also showed significant associations with a component of the California Verbal Learning Test-II, explaining 18% and 27% of the variance in performance, respectively.

The differences in stroke mortality between African Americans and Caucasians are largely related to differences in stroke incidence, according to a study published online ahead of print June 2 in Stroke. Researchers assessed the difference between African American and Caucasian stroke mortality for 29,681 participants in the Reasons for Geographic and Racial Differences in Stroke cohort. They found that African Americans are four times more likely to die of stroke at age 45 than Caucasians because stroke incidence is greater among African Americans. By age 85, however, the difference in stroke mortality is no longer present. More should be done to reduce the disparity in stroke mortality between African Americans and Caucasians, and interventions should focus on prevention of stroke among African Americans, according to the investigators.

A mutant transmembrane protein of synaptic vesicles in neurons is etiologically linked to Parkinson's disease, according to a study published online ahead of print June 6 in Nature Genetics. Researchers first investigated a family with 15 members who had typical symptoms of Parkinson's disease. They used DNA samples to perform a genome-wide analysis on 65 of the family's members, including 13 with Parkinson's disease, to find a common mutation that could explain the prevalence of Parkinson's disease. The study authors identified TMEM230 as the gene with a disease-causing mutation and found that TMEM230 encodes a protein that extends across the membrane of tiny sacs inside synaptic vesicles. The research team also found mutations in TMEM230 in cases of Parkinson's disease in additional families in North America and China.

People with blast exposure have a pattern of interface astroglial scarring at boundaries between brain parenchyma and fluids, and between gray and white matter, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers analyzed brain specimens from five military service members with chronic blast exposure, three with acute blast exposure, five with chronic impact traumatic brain injury, five with exposure to opiates, and three control cases with no known neurologic disorders. All five cases with chronic blast exposure showed prominent astroglial scarring involving the subpial glial plate, penetrating cortical blood vessels, gray-white matter junctions, and structures lining the ventricles. Cases of acute blast exposure showed early astroglial scarring in the same brain regions. Cases of chronic blast exposure had an antemortem diagnosis of posttraumatic stress disorder.

A combination of dextromethorphan and quinidine is an effective and well-tolerated treatment for pseudobulbar affect secondary to dementia, stroke, or traumatic brain injury, according to a study published June 9 in BMC Neurology. The study included 367 participants with this disorder. Participants in this open-label, multicenter, 90-day trial received dextromethorphan and quinidine twice daily. The mean Center for Neurologic Study-Lability Scale score improved from 20.4 at baseline to 12.8 at the 90-day final visit. Reduction in pseudobulbar affect episode count was 72.3% at the 90-day final visit, compared with baseline. Scores on Clinical Global Impression of Change and Patient Global Impression of Change indicated that 76.6% and 72.4% of participants, respectively, showed much or very much improvement in symptoms of pseudobulbar affect.

—Kimberly Williams

There is a strong, inverse association between midlife cardiorespiratory fitness and stroke risk in later life, independent of the baseline and antecedent burden of risk factors, according to a study published online ahead of print June 9 in Stroke. Researchers studied 19,815 individuals who received Medicare coverage from 1999 to 2009. Cardiorespiratory fitness estimated at baseline was analyzed as a continuous variable and according to age- and sex-specific quintiles. Associations between midlife cardiorespiratory fitness and stroke hospitalization after age 65 were assessed by applying a proportional hazards recurrent events model to failure time data with hypertension, diabetes mellitus, and atrial fibrillation as time-dependent covariates. The investigators observed 808 stroke hospitalizations. After adjustment for baseline risk factors, higher midlife cardiorespiratory fitness was associated with a lower risk of stroke hospitalization.

Incident dementia early after intracerebral hemorrhage is strongly associated with hematoma size and location, according to a study published online ahead of print June 13 in JAMA Neurology. A longitudinal study enrolled patients with intracerebral hemorrhage from January 1, 2006, to December 31, 2013. In all, 738 participants ages 18 or older, without pre-intracerebral hemorrhage dementia, who presented to a tertiary care academic institution with primary intracerebral hemorrhage were included in the study. A total of 140 patients developed dementia within six months. Larger hematoma size and lobar location of intracerebral hemorrhage were associated with early post-intracerebral hemorrhage dementia, but not with delayed post-intracerebral hemorrhage dementia. Educational level, incident mood symptoms, and white matter disease were associated with delayed, but not early, post-intracerebral hemorrhage dementia.

The FDA is investigating the risk of serious burns and potential permanent scarring from the use of the Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine. The patch delivers a dose of medicine in a single-use, battery-powered patch that is wrapped around the upper arm or thigh. Since the introduction of the patch, many patients have reported injury to the skin where the patch was worn. The reports include descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. Patients who experience moderate to severe pain at the patch site should immediately remove the patch to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact a health care professional. Teva Pharmaceuticals has suspended the sale, marketing, and distribution of the patch.

More than 90% of the global stroke burden is attributable to modifiable risk factors, including air pollution, and controlling behavioral and metabolic risk factors could avert more than 75% of the global stroke burden, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers used data on stroke-related disability-adjusted life-years, risk factors, and population-attributable fraction from the Global Burden of Disease Study 2013 to estimate the burden of stroke by age and sex in 188 countries. Approximately 74% of the global stroke burden was attributable to behavioral factors. Clusters of metabolic factors (72%) and environmental factors (33%) were the second and third largest contributors to disability-adjusted life-years, respectively. About 29% of the burden of stroke was attributed to air pollution.

Abnormally high fractional anisotropy (FA) on diffusion tensor imaging (DTI) is associated with better outcomes after mild traumatic brain injury (mTBI), according to a study published online ahead of print June 9 in the American Journal of Neuroradiology. DTI was performed on 39 subjects with mTBI within 16 days of injury and on 40 controls. In all, 26 subjects with mTBI returned for follow-up at one year. Among these subjects, high FA in the left frontal lobe and left temporal lobe was associated with better attention. High FA in the left and right cerebelli was associated with improved somatic postconcussion symptoms. High FA in the right thalamus was associated with improved emotional postconcussion symptoms. Abnormally high FA may be an imaging correlate of postinjury compensatory processes, said the investigators.

Among patients with multiple sclerosis (MS), obstructive sleep apnea and sleep disturbance are significantly associated with diminished visual memory, verbal memory, executive function, attention, processing speed, and working memory, according to a study published online ahead of print May 3 in Sleep. Thirty-eight participants underwent MS-specific cognitive testing and in-laboratory overnight polysomnography. In adjusted linear regression models, the oxygen desaturation index and minimum oxygen saturation were significantly associated with performance on multiple Minimal Assessment of Cognitive Function in MS measures. Apnea severity measures accounted for between 11% and 23% of the variance in cognitive test performance. Polysomnographic measures of sleep fragmentation and total sleep time also showed significant associations with a component of the California Verbal Learning Test-II, explaining 18% and 27% of the variance in performance, respectively.

The differences in stroke mortality between African Americans and Caucasians are largely related to differences in stroke incidence, according to a study published online ahead of print June 2 in Stroke. Researchers assessed the difference between African American and Caucasian stroke mortality for 29,681 participants in the Reasons for Geographic and Racial Differences in Stroke cohort. They found that African Americans are four times more likely to die of stroke at age 45 than Caucasians because stroke incidence is greater among African Americans. By age 85, however, the difference in stroke mortality is no longer present. More should be done to reduce the disparity in stroke mortality between African Americans and Caucasians, and interventions should focus on prevention of stroke among African Americans, according to the investigators.

A mutant transmembrane protein of synaptic vesicles in neurons is etiologically linked to Parkinson's disease, according to a study published online ahead of print June 6 in Nature Genetics. Researchers first investigated a family with 15 members who had typical symptoms of Parkinson's disease. They used DNA samples to perform a genome-wide analysis on 65 of the family's members, including 13 with Parkinson's disease, to find a common mutation that could explain the prevalence of Parkinson's disease. The study authors identified TMEM230 as the gene with a disease-causing mutation and found that TMEM230 encodes a protein that extends across the membrane of tiny sacs inside synaptic vesicles. The research team also found mutations in TMEM230 in cases of Parkinson's disease in additional families in North America and China.

People with blast exposure have a pattern of interface astroglial scarring at boundaries between brain parenchyma and fluids, and between gray and white matter, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers analyzed brain specimens from five military service members with chronic blast exposure, three with acute blast exposure, five with chronic impact traumatic brain injury, five with exposure to opiates, and three control cases with no known neurologic disorders. All five cases with chronic blast exposure showed prominent astroglial scarring involving the subpial glial plate, penetrating cortical blood vessels, gray-white matter junctions, and structures lining the ventricles. Cases of acute blast exposure showed early astroglial scarring in the same brain regions. Cases of chronic blast exposure had an antemortem diagnosis of posttraumatic stress disorder.

A combination of dextromethorphan and quinidine is an effective and well-tolerated treatment for pseudobulbar affect secondary to dementia, stroke, or traumatic brain injury, according to a study published June 9 in BMC Neurology. The study included 367 participants with this disorder. Participants in this open-label, multicenter, 90-day trial received dextromethorphan and quinidine twice daily. The mean Center for Neurologic Study-Lability Scale score improved from 20.4 at baseline to 12.8 at the 90-day final visit. Reduction in pseudobulbar affect episode count was 72.3% at the 90-day final visit, compared with baseline. Scores on Clinical Global Impression of Change and Patient Global Impression of Change indicated that 76.6% and 72.4% of participants, respectively, showed much or very much improvement in symptoms of pseudobulbar affect.

—Kimberly Williams

There is a strong, inverse association between midlife cardiorespiratory fitness and stroke risk in later life, independent of the baseline and antecedent burden of risk factors, according to a study published online ahead of print June 9 in Stroke. Researchers studied 19,815 individuals who received Medicare coverage from 1999 to 2009. Cardiorespiratory fitness estimated at baseline was analyzed as a continuous variable and according to age- and sex-specific quintiles. Associations between midlife cardiorespiratory fitness and stroke hospitalization after age 65 were assessed by applying a proportional hazards recurrent events model to failure time data with hypertension, diabetes mellitus, and atrial fibrillation as time-dependent covariates. The investigators observed 808 stroke hospitalizations. After adjustment for baseline risk factors, higher midlife cardiorespiratory fitness was associated with a lower risk of stroke hospitalization.

Incident dementia early after intracerebral hemorrhage is strongly associated with hematoma size and location, according to a study published online ahead of print June 13 in JAMA Neurology. A longitudinal study enrolled patients with intracerebral hemorrhage from January 1, 2006, to December 31, 2013. In all, 738 participants ages 18 or older, without pre-intracerebral hemorrhage dementia, who presented to a tertiary care academic institution with primary intracerebral hemorrhage were included in the study. A total of 140 patients developed dementia within six months. Larger hematoma size and lobar location of intracerebral hemorrhage were associated with early post-intracerebral hemorrhage dementia, but not with delayed post-intracerebral hemorrhage dementia. Educational level, incident mood symptoms, and white matter disease were associated with delayed, but not early, post-intracerebral hemorrhage dementia.

The FDA is investigating the risk of serious burns and potential permanent scarring from the use of the Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine. The patch delivers a dose of medicine in a single-use, battery-powered patch that is wrapped around the upper arm or thigh. Since the introduction of the patch, many patients have reported injury to the skin where the patch was worn. The reports include descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. Patients who experience moderate to severe pain at the patch site should immediately remove the patch to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact a health care professional. Teva Pharmaceuticals has suspended the sale, marketing, and distribution of the patch.

More than 90% of the global stroke burden is attributable to modifiable risk factors, including air pollution, and controlling behavioral and metabolic risk factors could avert more than 75% of the global stroke burden, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers used data on stroke-related disability-adjusted life-years, risk factors, and population-attributable fraction from the Global Burden of Disease Study 2013 to estimate the burden of stroke by age and sex in 188 countries. Approximately 74% of the global stroke burden was attributable to behavioral factors. Clusters of metabolic factors (72%) and environmental factors (33%) were the second and third largest contributors to disability-adjusted life-years, respectively. About 29% of the burden of stroke was attributed to air pollution.

Abnormally high fractional anisotropy (FA) on diffusion tensor imaging (DTI) is associated with better outcomes after mild traumatic brain injury (mTBI), according to a study published online ahead of print June 9 in the American Journal of Neuroradiology. DTI was performed on 39 subjects with mTBI within 16 days of injury and on 40 controls. In all, 26 subjects with mTBI returned for follow-up at one year. Among these subjects, high FA in the left frontal lobe and left temporal lobe was associated with better attention. High FA in the left and right cerebelli was associated with improved somatic postconcussion symptoms. High FA in the right thalamus was associated with improved emotional postconcussion symptoms. Abnormally high FA may be an imaging correlate of postinjury compensatory processes, said the investigators.

Among patients with multiple sclerosis (MS), obstructive sleep apnea and sleep disturbance are significantly associated with diminished visual memory, verbal memory, executive function, attention, processing speed, and working memory, according to a study published online ahead of print May 3 in Sleep. Thirty-eight participants underwent MS-specific cognitive testing and in-laboratory overnight polysomnography. In adjusted linear regression models, the oxygen desaturation index and minimum oxygen saturation were significantly associated with performance on multiple Minimal Assessment of Cognitive Function in MS measures. Apnea severity measures accounted for between 11% and 23% of the variance in cognitive test performance. Polysomnographic measures of sleep fragmentation and total sleep time also showed significant associations with a component of the California Verbal Learning Test-II, explaining 18% and 27% of the variance in performance, respectively.

The differences in stroke mortality between African Americans and Caucasians are largely related to differences in stroke incidence, according to a study published online ahead of print June 2 in Stroke. Researchers assessed the difference between African American and Caucasian stroke mortality for 29,681 participants in the Reasons for Geographic and Racial Differences in Stroke cohort. They found that African Americans are four times more likely to die of stroke at age 45 than Caucasians because stroke incidence is greater among African Americans. By age 85, however, the difference in stroke mortality is no longer present. More should be done to reduce the disparity in stroke mortality between African Americans and Caucasians, and interventions should focus on prevention of stroke among African Americans, according to the investigators.

A mutant transmembrane protein of synaptic vesicles in neurons is etiologically linked to Parkinson's disease, according to a study published online ahead of print June 6 in Nature Genetics. Researchers first investigated a family with 15 members who had typical symptoms of Parkinson's disease. They used DNA samples to perform a genome-wide analysis on 65 of the family's members, including 13 with Parkinson's disease, to find a common mutation that could explain the prevalence of Parkinson's disease. The study authors identified TMEM230 as the gene with a disease-causing mutation and found that TMEM230 encodes a protein that extends across the membrane of tiny sacs inside synaptic vesicles. The research team also found mutations in TMEM230 in cases of Parkinson's disease in additional families in North America and China.

People with blast exposure have a pattern of interface astroglial scarring at boundaries between brain parenchyma and fluids, and between gray and white matter, according to a study published online ahead of print June 9 in the Lancet Neurology. Researchers analyzed brain specimens from five military service members with chronic blast exposure, three with acute blast exposure, five with chronic impact traumatic brain injury, five with exposure to opiates, and three control cases with no known neurologic disorders. All five cases with chronic blast exposure showed prominent astroglial scarring involving the subpial glial plate, penetrating cortical blood vessels, gray-white matter junctions, and structures lining the ventricles. Cases of acute blast exposure showed early astroglial scarring in the same brain regions. Cases of chronic blast exposure had an antemortem diagnosis of posttraumatic stress disorder.

A combination of dextromethorphan and quinidine is an effective and well-tolerated treatment for pseudobulbar affect secondary to dementia, stroke, or traumatic brain injury, according to a study published June 9 in BMC Neurology. The study included 367 participants with this disorder. Participants in this open-label, multicenter, 90-day trial received dextromethorphan and quinidine twice daily. The mean Center for Neurologic Study-Lability Scale score improved from 20.4 at baseline to 12.8 at the 90-day final visit. Reduction in pseudobulbar affect episode count was 72.3% at the 90-day final visit, compared with baseline. Scores on Clinical Global Impression of Change and Patient Global Impression of Change indicated that 76.6% and 72.4% of participants, respectively, showed much or very much improvement in symptoms of pseudobulbar affect.

—Kimberly Williams

Illustrative Case

A 38-year-old woman recently diagnosed with MDD without a seasonal pattern comes to see you for her treatment options. Her Hamilton Depression Rating Scale (HAM-D) is 22, and she is not suicidal. Should you consider bright light therapy in addition to pharmacotherapy?

MDD is one of the most common psychiatric illnesses in the United States, affecting approximately one in 5 adults at some point in their lives.² Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors are considered effective first-line pharmacotherapy options for MDD.^2,3 Despite their effectiveness, however, studies have shown that only about 40% of patients with MDD achieve remission with first- or second-line drugs.² In addition, pharmacologic agents have a higher frequency of treatment-associated adverse effects than fluorescent light therapy.⁴

A Cochrane systematic review of 20 studies (N=620) showed the effectiveness of combined light therapy and pharmacotherapy in treating nonseasonal MDD, but found no benefit to light used as a monotherapy.⁵ However, the majority of the studies were of poor quality, occurred in the inpatient setting, and lasted fewer than 4 weeks.

In a 5-week, controlled, double-blind trial not included in the Cochrane review, 102 patients with nonseasonal MDD were randomized to receive either active treatment (bright light therapy) plus sertraline 50 mg daily or sham light treatment (using a dim red light) plus sertraline 50 mg daily. The investigators found a statistically significant larger reduction in depression score in the active treatment group than in the sham light group, based on the HAM-D, the Hamilton 6-Item Subscale, the Melancholia Scale, and the 7 atypical items from the Structured Interview Guide for the Seasonal Affective Disorder version of the HAM-D.^6,7

Study Summary 

Light therapy improves depression without a seasonal component

This latest study was an 8-week randomized, double-blind, placebo- and sham-controlled clinical trial evaluating the benefit of light therapy with and without pharmacotherapy for nonseasonal MDD.¹ The investigators enrolled 122 adult patients (ages 19-60 years) from outpatient psychiatry clinics with a diagnosis of MDD (as diagnosed by a psychiatrist) and a HAM-D⁸ score of at least 20. Subjects had to be off psychotropic medication for at least 2 weeks prior to the first visit and were subsequently monitored for one week to identify spontaneous responders and to give patients time to better regulate their sleep-wake cycle (with the goal of sleeping only between 10:00 pm and 8:00 am daily).

The investigators randomly assigned patients to one of 4 treatment groups: active light monotherapy (10,000-lux fluorescent white light for 30 min/d early in the morning) plus a placebo pill; fluoxetine 20 mg/d plus sham light therapy; placebo pills with sham light therapy; and combined active light therapy with fluoxetine 20 mg daily. Sham light therapy consisted of the use of an inactivated negative ion generator, used in the same fashion as a light box. All patients were analyzed based on modified intention to treat.

The investigators monitored patients for adherence to active and sham treatment by review of their daily logs of device treatment times. Pill counts were used to assess medication adherence. The primary outcome at 8 weeks was the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item questionnaire with a worst score of 60.⁹ Secondary outcomes were treatment response (≥50% MADRS score reduction) and remission (≤10 MADRS score) at the final 8th-week visit. MADRS scoring was used because of its higher sensitivity to treatment-induced changes and its high correlation with the HAM-D scale.

Seventy-six percent of patients treated with fluoxetine and light therapy saw at least a 50% improvement in their depression scores.

At the end of 8 weeks, the mean (standard deviation [SD]) changes in MADRS scores from baseline were: light monotherapy 13.4 (7.5), fluoxetine monotherapy 8.8 (9.9), combination therapy 16.9 (9.2), and placebo 6.5 (9.6). The improvement was significant in the light monotherapy treatment group vs the placebo group (P=.006), in the combination treatment group vs the vs placebo group (P<.001), and in the combination group vs the fluoxetine treatment group (P=.02), but not for the fluoxetine treatment group vs the placebo group (P=.32). The effect sizes vs placebo were: fluoxetine, d=0.24 (95% confidence interval [CI], −0.27 to 0.74); light monotherapy, 0.80 (95% CI, 0.28 to 1.31); and combination therapy, 1.11 (95% CI, 0.54 to 1.64). Effect sizes of more than 0.8 are often considered large.¹⁰

The treatment response (≥50% MADRS improvement) rate was highest in the combination treatment group (75.9%) with response rates to light monotherapy, placebo, and fluoxetine monotherapy of 50%, 33.3%, and 29%, respectively. There was a significant response effect for the combination vs placebo treatment group (P=.005). Similarly, there was a higher remission rate in the combination treatment group (58.6%) than in the placebo, light monotherapy, or fluoxetine treatment groups (30%, 43.8%, and 19.4%, respectively) with a significant effect for the combination vs placebo treatment group (P=.02).

Combination therapy was superior to placebo in treatment response (≥50% reduction in the MADRS score) and remission (MADRS ≤10) with numbers needed to treat of 2.4 (95% CI, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

By the end of the 8-week study period, 16 of 122 patients had dropped out; 2 reported lack of efficacy, 5 reported adverse effects, and the remainder cited administrative reasons, were lost to follow-up, or withdrew consent.

What’s New? 

New evidence on a not-so-new treatment

We now have evidence that bright light therapy, either alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal MDD.

Caveats 

Choice of SSRI, geography, and trial duration may have affected results

A single SSRI (fluoxetine) was used in this study; other more potent SSRIs might work better. This study was conducted in southern Canada, and light therapy may not demonstrate as large a benefit in regions located farther south. The study excluded pregnant and breastfeeding women.

The trial duration was relatively short, and the investigators did not attain their pre-planned sample size for the study, which limited the power to detect clinically significant seasonal treatment effects and differences between the fluoxetine and placebo groups, regardless of whether they received active phototherapy.

Also, it’s worth noting that there were trends for some adverse events (nausea, heartburn, weight gain, agitation, sexual dysfunction, and skin rash) to occur less frequently in the combination group than in the fluoxetine monotherapy group. Possible explanations are that the study had inadequate power, that the sham treatment did not adequately blind patients, or that light therapy can ameliorate some of the adverse effects of fluoxetine.

We now have evidence that bright light therapy, alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal major depressive disorder.

Challenges to Implementation

Commercial insurance doesn’t usually cover light therapy

Bright light therapy is fairly safe, and some evidence exists supporting its use in the treatment of nonseasonal MDD; however, the data for its use in this area are limited.¹¹ Since only a few studies have tested light therapy for nonseasonal MDD, significant uncertainty remains about patient selection, as well as optimal dose, timing, and duration of light therapy in the management of nonseasonal MDD.¹² Although the risks associated with bright light therapy are minimal, the therapy can lead to mania or hypomania,³ so clinicians need to monitor for such effects when initiating therapy.

Lastly, commercial insurance does not usually cover light therapy. The average price of the bright light devices, which can be found in medical supply stores and online outlets, ranges between $118 and $237.^4,12 However, such devices are reusable, making the amortized cost almost negligible.¹³

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative Case

A 38-year-old woman recently diagnosed with MDD without a seasonal pattern comes to see you for her treatment options. Her Hamilton Depression Rating Scale (HAM-D) is 22, and she is not suicidal. Should you consider bright light therapy in addition to pharmacotherapy?

MDD is one of the most common psychiatric illnesses in the United States, affecting approximately one in 5 adults at some point in their lives.² Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors are considered effective first-line pharmacotherapy options for MDD.^2,3 Despite their effectiveness, however, studies have shown that only about 40% of patients with MDD achieve remission with first- or second-line drugs.² In addition, pharmacologic agents have a higher frequency of treatment-associated adverse effects than fluorescent light therapy.⁴

A Cochrane systematic review of 20 studies (N=620) showed the effectiveness of combined light therapy and pharmacotherapy in treating nonseasonal MDD, but found no benefit to light used as a monotherapy.⁵ However, the majority of the studies were of poor quality, occurred in the inpatient setting, and lasted fewer than 4 weeks.

In a 5-week, controlled, double-blind trial not included in the Cochrane review, 102 patients with nonseasonal MDD were randomized to receive either active treatment (bright light therapy) plus sertraline 50 mg daily or sham light treatment (using a dim red light) plus sertraline 50 mg daily. The investigators found a statistically significant larger reduction in depression score in the active treatment group than in the sham light group, based on the HAM-D, the Hamilton 6-Item Subscale, the Melancholia Scale, and the 7 atypical items from the Structured Interview Guide for the Seasonal Affective Disorder version of the HAM-D.^6,7

Study Summary 

Light therapy improves depression without a seasonal component

This latest study was an 8-week randomized, double-blind, placebo- and sham-controlled clinical trial evaluating the benefit of light therapy with and without pharmacotherapy for nonseasonal MDD.¹ The investigators enrolled 122 adult patients (ages 19-60 years) from outpatient psychiatry clinics with a diagnosis of MDD (as diagnosed by a psychiatrist) and a HAM-D⁸ score of at least 20. Subjects had to be off psychotropic medication for at least 2 weeks prior to the first visit and were subsequently monitored for one week to identify spontaneous responders and to give patients time to better regulate their sleep-wake cycle (with the goal of sleeping only between 10:00 pm and 8:00 am daily).

The investigators randomly assigned patients to one of 4 treatment groups: active light monotherapy (10,000-lux fluorescent white light for 30 min/d early in the morning) plus a placebo pill; fluoxetine 20 mg/d plus sham light therapy; placebo pills with sham light therapy; and combined active light therapy with fluoxetine 20 mg daily. Sham light therapy consisted of the use of an inactivated negative ion generator, used in the same fashion as a light box. All patients were analyzed based on modified intention to treat.

The investigators monitored patients for adherence to active and sham treatment by review of their daily logs of device treatment times. Pill counts were used to assess medication adherence. The primary outcome at 8 weeks was the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item questionnaire with a worst score of 60.⁹ Secondary outcomes were treatment response (≥50% MADRS score reduction) and remission (≤10 MADRS score) at the final 8th-week visit. MADRS scoring was used because of its higher sensitivity to treatment-induced changes and its high correlation with the HAM-D scale.

Seventy-six percent of patients treated with fluoxetine and light therapy saw at least a 50% improvement in their depression scores.

At the end of 8 weeks, the mean (standard deviation [SD]) changes in MADRS scores from baseline were: light monotherapy 13.4 (7.5), fluoxetine monotherapy 8.8 (9.9), combination therapy 16.9 (9.2), and placebo 6.5 (9.6). The improvement was significant in the light monotherapy treatment group vs the placebo group (P=.006), in the combination treatment group vs the vs placebo group (P<.001), and in the combination group vs the fluoxetine treatment group (P=.02), but not for the fluoxetine treatment group vs the placebo group (P=.32). The effect sizes vs placebo were: fluoxetine, d=0.24 (95% confidence interval [CI], −0.27 to 0.74); light monotherapy, 0.80 (95% CI, 0.28 to 1.31); and combination therapy, 1.11 (95% CI, 0.54 to 1.64). Effect sizes of more than 0.8 are often considered large.¹⁰

The treatment response (≥50% MADRS improvement) rate was highest in the combination treatment group (75.9%) with response rates to light monotherapy, placebo, and fluoxetine monotherapy of 50%, 33.3%, and 29%, respectively. There was a significant response effect for the combination vs placebo treatment group (P=.005). Similarly, there was a higher remission rate in the combination treatment group (58.6%) than in the placebo, light monotherapy, or fluoxetine treatment groups (30%, 43.8%, and 19.4%, respectively) with a significant effect for the combination vs placebo treatment group (P=.02).

Combination therapy was superior to placebo in treatment response (≥50% reduction in the MADRS score) and remission (MADRS ≤10) with numbers needed to treat of 2.4 (95% CI, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

By the end of the 8-week study period, 16 of 122 patients had dropped out; 2 reported lack of efficacy, 5 reported adverse effects, and the remainder cited administrative reasons, were lost to follow-up, or withdrew consent.

What’s New? 

New evidence on a not-so-new treatment

We now have evidence that bright light therapy, either alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal MDD.

Caveats 

Choice of SSRI, geography, and trial duration may have affected results

A single SSRI (fluoxetine) was used in this study; other more potent SSRIs might work better. This study was conducted in southern Canada, and light therapy may not demonstrate as large a benefit in regions located farther south. The study excluded pregnant and breastfeeding women.

The trial duration was relatively short, and the investigators did not attain their pre-planned sample size for the study, which limited the power to detect clinically significant seasonal treatment effects and differences between the fluoxetine and placebo groups, regardless of whether they received active phototherapy.

Also, it’s worth noting that there were trends for some adverse events (nausea, heartburn, weight gain, agitation, sexual dysfunction, and skin rash) to occur less frequently in the combination group than in the fluoxetine monotherapy group. Possible explanations are that the study had inadequate power, that the sham treatment did not adequately blind patients, or that light therapy can ameliorate some of the adverse effects of fluoxetine.

We now have evidence that bright light therapy, alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal major depressive disorder.

Challenges to Implementation

Commercial insurance doesn’t usually cover light therapy

Bright light therapy is fairly safe, and some evidence exists supporting its use in the treatment of nonseasonal MDD; however, the data for its use in this area are limited.¹¹ Since only a few studies have tested light therapy for nonseasonal MDD, significant uncertainty remains about patient selection, as well as optimal dose, timing, and duration of light therapy in the management of nonseasonal MDD.¹² Although the risks associated with bright light therapy are minimal, the therapy can lead to mania or hypomania,³ so clinicians need to monitor for such effects when initiating therapy.

Lastly, commercial insurance does not usually cover light therapy. The average price of the bright light devices, which can be found in medical supply stores and online outlets, ranges between $118 and $237.^4,12 However, such devices are reusable, making the amortized cost almost negligible.¹³

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

Illustrative Case

A 38-year-old woman recently diagnosed with MDD without a seasonal pattern comes to see you for her treatment options. Her Hamilton Depression Rating Scale (HAM-D) is 22, and she is not suicidal. Should you consider bright light therapy in addition to pharmacotherapy?

MDD is one of the most common psychiatric illnesses in the United States, affecting approximately one in 5 adults at some point in their lives.² Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors are considered effective first-line pharmacotherapy options for MDD.^2,3 Despite their effectiveness, however, studies have shown that only about 40% of patients with MDD achieve remission with first- or second-line drugs.² In addition, pharmacologic agents have a higher frequency of treatment-associated adverse effects than fluorescent light therapy.⁴

A Cochrane systematic review of 20 studies (N=620) showed the effectiveness of combined light therapy and pharmacotherapy in treating nonseasonal MDD, but found no benefit to light used as a monotherapy.⁵ However, the majority of the studies were of poor quality, occurred in the inpatient setting, and lasted fewer than 4 weeks.

In a 5-week, controlled, double-blind trial not included in the Cochrane review, 102 patients with nonseasonal MDD were randomized to receive either active treatment (bright light therapy) plus sertraline 50 mg daily or sham light treatment (using a dim red light) plus sertraline 50 mg daily. The investigators found a statistically significant larger reduction in depression score in the active treatment group than in the sham light group, based on the HAM-D, the Hamilton 6-Item Subscale, the Melancholia Scale, and the 7 atypical items from the Structured Interview Guide for the Seasonal Affective Disorder version of the HAM-D.^6,7

Study Summary 

Light therapy improves depression without a seasonal component

This latest study was an 8-week randomized, double-blind, placebo- and sham-controlled clinical trial evaluating the benefit of light therapy with and without pharmacotherapy for nonseasonal MDD.¹ The investigators enrolled 122 adult patients (ages 19-60 years) from outpatient psychiatry clinics with a diagnosis of MDD (as diagnosed by a psychiatrist) and a HAM-D⁸ score of at least 20. Subjects had to be off psychotropic medication for at least 2 weeks prior to the first visit and were subsequently monitored for one week to identify spontaneous responders and to give patients time to better regulate their sleep-wake cycle (with the goal of sleeping only between 10:00 pm and 8:00 am daily).

The investigators randomly assigned patients to one of 4 treatment groups: active light monotherapy (10,000-lux fluorescent white light for 30 min/d early in the morning) plus a placebo pill; fluoxetine 20 mg/d plus sham light therapy; placebo pills with sham light therapy; and combined active light therapy with fluoxetine 20 mg daily. Sham light therapy consisted of the use of an inactivated negative ion generator, used in the same fashion as a light box. All patients were analyzed based on modified intention to treat.

The investigators monitored patients for adherence to active and sham treatment by review of their daily logs of device treatment times. Pill counts were used to assess medication adherence. The primary outcome at 8 weeks was the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item questionnaire with a worst score of 60.⁹ Secondary outcomes were treatment response (≥50% MADRS score reduction) and remission (≤10 MADRS score) at the final 8th-week visit. MADRS scoring was used because of its higher sensitivity to treatment-induced changes and its high correlation with the HAM-D scale.

Seventy-six percent of patients treated with fluoxetine and light therapy saw at least a 50% improvement in their depression scores.

At the end of 8 weeks, the mean (standard deviation [SD]) changes in MADRS scores from baseline were: light monotherapy 13.4 (7.5), fluoxetine monotherapy 8.8 (9.9), combination therapy 16.9 (9.2), and placebo 6.5 (9.6). The improvement was significant in the light monotherapy treatment group vs the placebo group (P=.006), in the combination treatment group vs the vs placebo group (P<.001), and in the combination group vs the fluoxetine treatment group (P=.02), but not for the fluoxetine treatment group vs the placebo group (P=.32). The effect sizes vs placebo were: fluoxetine, d=0.24 (95% confidence interval [CI], −0.27 to 0.74); light monotherapy, 0.80 (95% CI, 0.28 to 1.31); and combination therapy, 1.11 (95% CI, 0.54 to 1.64). Effect sizes of more than 0.8 are often considered large.¹⁰

The treatment response (≥50% MADRS improvement) rate was highest in the combination treatment group (75.9%) with response rates to light monotherapy, placebo, and fluoxetine monotherapy of 50%, 33.3%, and 29%, respectively. There was a significant response effect for the combination vs placebo treatment group (P=.005). Similarly, there was a higher remission rate in the combination treatment group (58.6%) than in the placebo, light monotherapy, or fluoxetine treatment groups (30%, 43.8%, and 19.4%, respectively) with a significant effect for the combination vs placebo treatment group (P=.02).

Combination therapy was superior to placebo in treatment response (≥50% reduction in the MADRS score) and remission (MADRS ≤10) with numbers needed to treat of 2.4 (95% CI, 1.6-5.8) and 3.5 (95% CI, 2.0-29.9), respectively.

By the end of the 8-week study period, 16 of 122 patients had dropped out; 2 reported lack of efficacy, 5 reported adverse effects, and the remainder cited administrative reasons, were lost to follow-up, or withdrew consent.

What’s New? 

New evidence on a not-so-new treatment

We now have evidence that bright light therapy, either alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal MDD.

Caveats 

Choice of SSRI, geography, and trial duration may have affected results

A single SSRI (fluoxetine) was used in this study; other more potent SSRIs might work better. This study was conducted in southern Canada, and light therapy may not demonstrate as large a benefit in regions located farther south. The study excluded pregnant and breastfeeding women.

The trial duration was relatively short, and the investigators did not attain their pre-planned sample size for the study, which limited the power to detect clinically significant seasonal treatment effects and differences between the fluoxetine and placebo groups, regardless of whether they received active phototherapy.

Also, it’s worth noting that there were trends for some adverse events (nausea, heartburn, weight gain, agitation, sexual dysfunction, and skin rash) to occur less frequently in the combination group than in the fluoxetine monotherapy group. Possible explanations are that the study had inadequate power, that the sham treatment did not adequately blind patients, or that light therapy can ameliorate some of the adverse effects of fluoxetine.

We now have evidence that bright light therapy, alone or in combination with fluoxetine, is efficacious in increasing the remission rate of nonseasonal major depressive disorder.

Challenges to Implementation

Commercial insurance doesn’t usually cover light therapy

Bright light therapy is fairly safe, and some evidence exists supporting its use in the treatment of nonseasonal MDD; however, the data for its use in this area are limited.¹¹ Since only a few studies have tested light therapy for nonseasonal MDD, significant uncertainty remains about patient selection, as well as optimal dose, timing, and duration of light therapy in the management of nonseasonal MDD.¹² Although the risks associated with bright light therapy are minimal, the therapy can lead to mania or hypomania,³ so clinicians need to monitor for such effects when initiating therapy.

Lastly, commercial insurance does not usually cover light therapy. The average price of the bright light devices, which can be found in medical supply stores and online outlets, ranges between $118 and $237.^4,12 However, such devices are reusable, making the amortized cost almost negligible.¹³

ACKNOWLEDGEMENT
The PURLs Surveillance System was supported in part by Grant Number UL1RR024999 from the National Center For Research Resources, a Clinical Translational Science Award to the University of Chicago. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center For Research Resources or the National Institutes of Health.

The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

Click on the PDF icon at the top of this introduction to read the full article.

The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

Click on the PDF icon at the top of this introduction to read the full article.

The past 5 years have witnessed a watershed moment in the management of metastatic melanoma. The successes of molecularly targeted and immune-based therapies have transformed it from an aggressively lethal malignancy into one that is readily treatable. Here, we discuss continued efforts to find new therapies and broaden the clinical impact of existing options to maintain the unprecedented momentum of improving patient outcomes.

Click on the PDF icon at the top of this introduction to read the full article.

Background Group-based services can improve quality-of-life outcomes for oncology patients.

Objective To assess patient preferences for supportive and wellness programming to better meet patient needs and allocate resources.

Methods Patients from 3 cancer centers in New York City completed a 15-item questionnaire about their interest in educational topics (wellness, nutrition, legal issues, etc) and services (support groups, lectures, and exercise programs).

Results 311 patients participated in the survey. Mean age was 59 years, and 74% were women. The most common cancer was breast (40%), followed by genitourinary (15%). Women preferred wellness workshops most, followed by informative sessions; men most preferred informative sessions, followed equally by posttreatment support and wellness workshops. Older age was related to an increased likelihood of group attendance. Overall, 68% of participants reported that they would be likely to attend groups. For lectures, nutrition was of greatest interest for men (43%) and women (34%), followed by anxiety management (17% and 18%, respectively). Overall, 64% of participants reported that they would be likely to attend a lecture. A majority of respondents (54%) expressed a desire for exercise programs.

Limitations Generalizability to all cancer centers is limited, because data was not tracked on those who refused to complete the questionnaire.

Conclusions Obtaining patient feedback on psychosocial programs is imperative for understanding patient preferences and developing effective support programming.

Click on the PDF icon at the top of this introduction to read the full article.​

Background Group-based services can improve quality-of-life outcomes for oncology patients.

Objective To assess patient preferences for supportive and wellness programming to better meet patient needs and allocate resources.

Methods Patients from 3 cancer centers in New York City completed a 15-item questionnaire about their interest in educational topics (wellness, nutrition, legal issues, etc) and services (support groups, lectures, and exercise programs).

Results 311 patients participated in the survey. Mean age was 59 years, and 74% were women. The most common cancer was breast (40%), followed by genitourinary (15%). Women preferred wellness workshops most, followed by informative sessions; men most preferred informative sessions, followed equally by posttreatment support and wellness workshops. Older age was related to an increased likelihood of group attendance. Overall, 68% of participants reported that they would be likely to attend groups. For lectures, nutrition was of greatest interest for men (43%) and women (34%), followed by anxiety management (17% and 18%, respectively). Overall, 64% of participants reported that they would be likely to attend a lecture. A majority of respondents (54%) expressed a desire for exercise programs.

Limitations Generalizability to all cancer centers is limited, because data was not tracked on those who refused to complete the questionnaire.

Conclusions Obtaining patient feedback on psychosocial programs is imperative for understanding patient preferences and developing effective support programming.

Click on the PDF icon at the top of this introduction to read the full article.​

Background Group-based services can improve quality-of-life outcomes for oncology patients.

Objective To assess patient preferences for supportive and wellness programming to better meet patient needs and allocate resources.

Methods Patients from 3 cancer centers in New York City completed a 15-item questionnaire about their interest in educational topics (wellness, nutrition, legal issues, etc) and services (support groups, lectures, and exercise programs).

Results 311 patients participated in the survey. Mean age was 59 years, and 74% were women. The most common cancer was breast (40%), followed by genitourinary (15%). Women preferred wellness workshops most, followed by informative sessions; men most preferred informative sessions, followed equally by posttreatment support and wellness workshops. Older age was related to an increased likelihood of group attendance. Overall, 68% of participants reported that they would be likely to attend groups. For lectures, nutrition was of greatest interest for men (43%) and women (34%), followed by anxiety management (17% and 18%, respectively). Overall, 64% of participants reported that they would be likely to attend a lecture. A majority of respondents (54%) expressed a desire for exercise programs.

Limitations Generalizability to all cancer centers is limited, because data was not tracked on those who refused to complete the questionnaire.

Conclusions Obtaining patient feedback on psychosocial programs is imperative for understanding patient preferences and developing effective support programming.

Click on the PDF icon at the top of this introduction to read the full article.​

The PD-1 immune checkpoint inhibitor nivolumab may be safe and effective as a first-line therapy in adult patients with non–small cell lung cancer (NSCLC), according to the results of the phase I CheckMate 012 trial.

Of 52 adult patients with advanced NSCLC who received nivolumab, 19% experienced grade three or four adverse events, and the overall response rate was 23% with four ongoing complete responses, reported Scott Gettinger, MD, of the Yale Cancer Center, New Haven, Conn., and his associates (J Clin Oncol. 2016 June. doi: 10.1200/JCO.2016.66.9929).

©Sebastian Kaulitzki/Thinkstock

In the study cohort, 94% had stage IV NSCLC, 79% were former or current smokers, and 65% had received either radiotherapy, adjuvant or neoadjuvant chemotherapy.

Treatment-related adverse events were reported in 71% of patients, the most common being fatigue (29%), rash (19%), and nausea (14%). Grade 3 or 4 adverse events including rash, cardiac failure, and lung infection occurred in 10 patients (19%). There were no treatment-related deaths, but adverse events led to the discontinuation of the drug treatment in six patients.

Responses to nivolumab (overall response rate, 23%) were durable with duration of responses ranging from 4.2 to 25.8 months. In addition, the median overall survival was 19.4 months, median progression-free survival was 3.5 months, and the 24-week progression-free survival rate was 31% (95% confidence interval, 28%-60%).

Forty-six patients had tumor specimens evaluable for PD-L1 expression. Clinical activity was observed regardless of PD-L1 expression, the investigators reported. However, the overall response rate was higher in patients with tumors that expressed PD-L1, compared with non-PD-L1-expressing tumors.

All investigators reported serving in advisory roles for, receiving financial compensation or honoraria from, or having ownership or stock in multiple companies including Bristol-Myers Squibb, which funded the study.

[email protected]

On Twitter @jessnicolecraig

The PD-1 immune checkpoint inhibitor nivolumab may be safe and effective as a first-line therapy in adult patients with non–small cell lung cancer (NSCLC), according to the results of the phase I CheckMate 012 trial.

Of 52 adult patients with advanced NSCLC who received nivolumab, 19% experienced grade three or four adverse events, and the overall response rate was 23% with four ongoing complete responses, reported Scott Gettinger, MD, of the Yale Cancer Center, New Haven, Conn., and his associates (J Clin Oncol. 2016 June. doi: 10.1200/JCO.2016.66.9929).

©Sebastian Kaulitzki/Thinkstock

In the study cohort, 94% had stage IV NSCLC, 79% were former or current smokers, and 65% had received either radiotherapy, adjuvant or neoadjuvant chemotherapy.

Treatment-related adverse events were reported in 71% of patients, the most common being fatigue (29%), rash (19%), and nausea (14%). Grade 3 or 4 adverse events including rash, cardiac failure, and lung infection occurred in 10 patients (19%). There were no treatment-related deaths, but adverse events led to the discontinuation of the drug treatment in six patients.

Responses to nivolumab (overall response rate, 23%) were durable with duration of responses ranging from 4.2 to 25.8 months. In addition, the median overall survival was 19.4 months, median progression-free survival was 3.5 months, and the 24-week progression-free survival rate was 31% (95% confidence interval, 28%-60%).

Forty-six patients had tumor specimens evaluable for PD-L1 expression. Clinical activity was observed regardless of PD-L1 expression, the investigators reported. However, the overall response rate was higher in patients with tumors that expressed PD-L1, compared with non-PD-L1-expressing tumors.

All investigators reported serving in advisory roles for, receiving financial compensation or honoraria from, or having ownership or stock in multiple companies including Bristol-Myers Squibb, which funded the study.

[email protected]

On Twitter @jessnicolecraig

The PD-1 immune checkpoint inhibitor nivolumab may be safe and effective as a first-line therapy in adult patients with non–small cell lung cancer (NSCLC), according to the results of the phase I CheckMate 012 trial.

Of 52 adult patients with advanced NSCLC who received nivolumab, 19% experienced grade three or four adverse events, and the overall response rate was 23% with four ongoing complete responses, reported Scott Gettinger, MD, of the Yale Cancer Center, New Haven, Conn., and his associates (J Clin Oncol. 2016 June. doi: 10.1200/JCO.2016.66.9929).

©Sebastian Kaulitzki/Thinkstock

In the study cohort, 94% had stage IV NSCLC, 79% were former or current smokers, and 65% had received either radiotherapy, adjuvant or neoadjuvant chemotherapy.

Treatment-related adverse events were reported in 71% of patients, the most common being fatigue (29%), rash (19%), and nausea (14%). Grade 3 or 4 adverse events including rash, cardiac failure, and lung infection occurred in 10 patients (19%). There were no treatment-related deaths, but adverse events led to the discontinuation of the drug treatment in six patients.

Responses to nivolumab (overall response rate, 23%) were durable with duration of responses ranging from 4.2 to 25.8 months. In addition, the median overall survival was 19.4 months, median progression-free survival was 3.5 months, and the 24-week progression-free survival rate was 31% (95% confidence interval, 28%-60%).

Forty-six patients had tumor specimens evaluable for PD-L1 expression. Clinical activity was observed regardless of PD-L1 expression, the investigators reported. However, the overall response rate was higher in patients with tumors that expressed PD-L1, compared with non-PD-L1-expressing tumors.

All investigators reported serving in advisory roles for, receiving financial compensation or honoraria from, or having ownership or stock in multiple companies including Bristol-Myers Squibb, which funded the study.

[email protected]

On Twitter @jessnicolecraig

Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

Click on the PDF icon at the top of this introduction to read the full article.

Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

Click on the PDF icon at the top of this introduction to read the full article.

Background Emergency department (ED) use and hospitalization is distressing to cancer patients and drives up the cost of health care. A growing body of evidence demonstrates that more than half of those visits may be avoidable.

Objective To examine the impact of a nurse practitioner (NP)-led, physician-supervised, outpatient symptom management clinic on ED use.

Methods We conducted a retrospective review of ED encounters to quantify the frequency of ED use by oncology patients at a community cancer institute 6 months before (October 2012-March 2013) and after (April-September 2013) the initiation of an NP-staffed symptom management clinic.

Results The highest use of the ED and supportive clinic was among patients with advanced cancer, most commonly with lung or breast cancer, who were receiving cytotoxic chemotherapy. Uncontrolled symptoms of shortness of breath, pain, weakness, fever, nausea, vomiting, and diarrhea commonly led to ED visits. Despite instituting the NP-staffed symptom management clinic to manage those symptoms, there was a 17.9% increase in ED use. However, of the patients seen by the NP, 95% may have avoided hospitalization.

Limitations Retrospective study

Conclusions Our study identifies a high-risk population of patients who use the ED frequently. NP-led clinics could aggressively manage the symptom burden of these patients and potentially reduce ED visits as other studies have demonstrated. Although our study did not directly demonstrate this, we have identified weaknesses of care delivery in our clinic that could be optimized. In addition, we have demonstrated that the majority of patients seen for acute symptoms by an NP avoided an ED visit. 

Click on the PDF icon at the top of this introduction to read the full article.

Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

Patients coinfected with hepatitis B virus and HIV are at greater risk for in-hospital mortality, particularly in liver-related admissions, compared with HBV monoinfection, according to a study in the Journal of Viral Hepatitis.

Researchers at Massachusetts General Hospital, Boston, identified patients in the 2011 U.S. Nationwide Inpatient Sample who had been hospitalized with HBV or HIV monoinfection or HBV/HIV coinfection using ICD-9-CM codes. A total of 72,584 discharges with HBV monoinfection, 133,880 discharges with HIV monoinfection and 8,156 discharges with HBV/HIV coinfection were included. The researchers then compared liver-related hospital admissions among the three groups and performed multivariable logistic regression to identify independent predictors of in-hospital mortality, length of stay, and total charges.

CDC/Dr. Erskine Palmer

According to Raymond T. Chung, MD, director of hepatology at Massachusetts General Hospital, and his coauthors, this study is the first to examine outcomes of HBV/HIV coinfection among hospitalized patients, a “group that represents those with advanced disease and vulnerable to poor outcomes and high health care utilization.” (J Viral Hepat. 2016 Jun 13. doi: 10.1111/jvh.12555)

Patients in the study with HBV monoinfection tended to be older than those with HIV monoinfection or HBV/HIV coinfection. Of those aged 51-65 years, 42% had HBV monoinfection, 34% had HIV monoinfection, and 31% had HBV/HIV coinfection (P less than .001). Males were overrepresented in the HBV/HIV coinfection group (77%), compared with those with HBV monoinfection (57%), and HIV monoinfection (67%). Additionally, the investigators found that patients with HBV monoinfection were more likely to be white (42%) than were those with HIV monoinfection (26%) or HBV/HIV coinfection (27%).

Dr. Chung and his colleagues found that HBV/HIV coinfection was associated with significantly higher adjusted in-hospital mortality, compared with patients with HBV monoinfection (adjusted odds ratio, 1.67; 95% confidence interval, 1.30-2.15), but not compared with HIV monoinfection (aOR, 1.22; 95% CI, 0.96-1.54).

“Interestingly, [the] increase in risk of mortality was primarily observed in liver-related admissions … and not infectious-related hospitalizations,” Dr. Chung and his coauthors said.

The overall adjusted hospital length of stay (LOS;1.53 days; 95% CI, 0.93-2.13; less than .001) and total hospitalization charges ($17,595; 95% CI 11,120-24,069; P less than .0001) were higher in the coinfected group, compared with the HBV monoinfection group – even after adjustment for comorbidity- and disease-related complications, the authors wrote. LOS and total charges also were higher in the coinfected group, compared with the HIV monoinfection group (+0.62 days; P = .034; $8,840; P = .005).

While HBV/HIV coinfection by itself was not associated with higher in-hospital mortality, the presence of HBV along with cirrhosis or complications of portal hypertension was associated with three times greater in-hospital mortality in patients with HIV, compared with those without such complications (odds ratio, 3.00; 95% CI, 1.80-5.02). Researchers also found that LOS (0.62 days; 95% CI, 0.05-1.20; P = .034) and hospitalization cost ($8,840; 95% CI, 2,604-15,077; P = .005) were increased in patients with HBV/HIV coinfection, compared with HIV monoinfection.

“Overall health care utilization from HBV/HIV coinfection is … higher than for either infection alone and higher than the national average for all hospitalizations, emphasizing the health care burden from these illnesses,” the authors concluded.

Three study coauthors were supported in part by grants from the National Institutes of Health, while one coauthor was supported by a career development award from the American Gastroenterological Association and by the National Institute of Diabetes and Digestive and Kidney Diseases. Dr. Chung reported no financial conflict of interests. One coauthor reported participation on scientific advisory boards of AbbVie and Cubist pharmaceuticals.

[email protected]

On Twitter @richpizzi

The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.

The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.

The American Heart Association/American Stroke Association has issued its first guideline on adult stroke rehabilitation. Published in the June issue of Stroke, the guideline calls for intensive, multidisciplinary treatment in an inpatient rehabilitation facility.

“Previous guidelines have focused on the medical issues involved in the initial management of stroke, but many people survive a stroke with some level of disability. There is increasing evidence that rehabilitation can have a big impact on the survivors’ quality of life, so the time is right to review the evidence in this complex field and highlight effective and important aspects of rehabilitation,” said Carolee J. Winstein, PhD, PT, lead author of the guideline and Professor of Biokinesiology and Physical Therapy at the University of Southern California in Los Angeles.

Carolee J. Winstein, PhD, PT

The American Stroke Association strongly recommends that stroke patients be treated at an inpatient rehabilitation facility whenever possible, rather than at a skilled nursing facility. While in an inpatient rehabilitation facility, a patient participates in at least three hours of rehabilitation per day with physical therapists, occupational therapists, and speech therapists. Nurses are continuously available, and doctors typically visit daily.

“There is considerable evidence that patients benefit from the team approach in a facility that understands the importance of rehabilitation during the early period after a stroke,” said Dr. Winstein.

According to Dr. Winstein and her coauthors, caregivers should advocate for discharge to an inpatient rehabilitation facility and insist that a stroke survivor not be discharged from the hospital until he or she has participated in a structured program on preventing falls. This program should include education about changes to make the home safer (eg, removing throw rugs and improving lighting), minimizing the fall risk resulting from the side effects of medication, and safely using assistive devices such as wheelchairs, walkers, and canes.

“This recommendation will probably change medical practice. Even the top stroke centers may not have a formal falls-prevention program, but it is very important because a high percentage of patients end up falling after a stroke,” Dr. Winstein said.

The guideline also recommends the following measures:

• Intense mobility-task training after stroke for all survivors with walking limitations to relearn activities such as climbing stairs

• An individually tailored exercise program that allows survivors to safely continue to improve their cardiovascular fitness through proper exercise and physical activity after formal rehabilitation is complete

• An enriched environment (which might include a computer, books, music, and games) to increase engagement and cognitive activities during rehabilitation

• Speech therapy for those with difficulty speaking following a stroke

• Eye exercises for survivors with difficulty focusing on near objects

• A balance training program for survivors with poor balance, or who are at risk for falls.

“For a person to fulfill his or her full potential after stroke, there needs to be a coordinated effort and ongoing communication between a team of professionals, as well as the patient, family, and caregivers,” Dr. Winstein said.